Recruiting

Gait Training

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07087769

Conditions

Stroke

Split-belt Treadmill

Resistance Exercise

Feedback

Gait Training

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Interventions

Treadmill Walking with Split-Belt and/or Tied-Belt Conditions

Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity

Sensory Feedback Training

Study Details

Brief summary:

This single-session study aims to evaluate a novel gait training protocol that integrates mechanical constraints and sensory feedback to enhance paretic leg propulsion in individuals post-stroke. The study will include 15 individuals who have experienced a stroke and 15 healthy adults, each aged 20 years or older. Participants will walk on both tied-belt and split-belt treadmills under various training conditions, including backward-directed resistance (applied at the pelvis, ankle, or both) and real-time sensory feedback (visual, auditory, or combined). These interventions will be applied individually and in combination to identify the most effective environment for promoting symmetrical gait patterns. Each session will last approximately two hours. The equipment used is non-invasive, and the risk to participants is minimal.

Conditions

Stroke

Split-belt Treadmill

Resistance Exercise

Feedback

Gait Training

Study ID

NCT07087769

Start date

Jul 25, 2025

Status verified date

Mar, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Accepted

Inclusion Criteria:

Aged 20 years or older

For stroke group: clinical diagnosis of stroke at least 1 month prior to participation

Ability to walk at least 10 meters with or without assistive devices

For healthy group: able to walk independently without assistive devices

Exclusion Criteria:

Life expectancy less than one year

Comatose or unable to follow three-step commands

Amputation of any lower limb

Poorly controlled diabetes (e.g., foot ulceration)

Blindness

Progressive neurological disease

Medically unstable condition

Significant musculoskeletal impairments affecting gait

Congestive heart failure or unstable angina

Peripheral vascular disease

Severe neuropsychiatric conditions (e.g., dementia, cognitive deficits, severe depression)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Gait Training with Combined Sensory Feedback and Mechanical Constraints

All participants will receive various gait training conditions during a single session. Conditions include treadmill walking (tied-belt and split-belt), backward-directed resistance (applied at pelvis, ankle, or both), sensory feedback (visual, auditory, or combined), and a final combined condition integrating both resistance and feedback. This is a within-subject crossover design.

Interventions

Treadmill Walking with Split-Belt and/or Tied-Belt Conditions

Participants will walk on an instrumented treadmill under split-belt and/or tied-belt conditions depending on their walking capacity. The belt speeds will be adjusted to facilitate locomotor adaptation and evaluate propulsion symmetry.

Mechanical Resistance (Pelvis and/or Ankle) depending on participant's walking capacity

Participants will walk on a treadmill (Split-belt and/or Tied-belt) with backward-directed resistance applied at the pelvis, ankle, or both. The resistance is used to challenge paretic leg propulsion and assess adaptive gait responses.

Sensory Feedback Training

Real-time feedback-visual, auditory, or combined-will be provided based on the propulsive force generated during split-belt and/or tied-belt treadmill walking, with or without mechanical resistance.

Primary outcome measure

  • Change in Paretic Leg Propulsive Force [ Time Frame: Within a single session (approximately 2 hours) ]

Central Contacts and Locations

Central contacts

Mansoo Ko, PhD

409-747-1617mako@utmb.edu

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Mansoo Ko

409-772-9555mako@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-04-01.